Drug Products That Present Demonstrable Difficulties for Compounding Under the Federal Food, Drug, and Cosmetic Act; Establishment of a Public Docket

The Food and Drug Administration (FDA or Agency) is developing a list of drug products and categories of drug products that present demonstrable difficulties for compounding (the Difficult to Compound List). The Agency previously solicited nominations for this list and received approximately 71 unique nominations. FDA is establishing a new public docket so that interested parties can nominate drug products or categories of drug products that were not previously nominated for inclusion on the Difficult to Compound List, resubmit previous nominations with additional supporting information, or submit comments.